Ethical issues in oocyte banking for nonautologous use: an Ethics Committee opinion.

Ethical considerations for the banking of oocytes for nonautologous use are discussed.

Does bariatric surgery reduce future hospital costs? A propensity score-matched analysis using UK Biobank Study data.

OBJECTIVES: To estimate the hospital costs among persons with obesity undergoing bariatric surgery compared with those without bariatric surgery. METHODS: We analysed the UK Biobank Cohort study linked to Hospital Episode Statistics, for all adults with obesity undergoing bariatric surgery at National Health Service hospitals in England, Scotland, or Wales from 2006 to 2017. Surgery patients were matched with controls who did not have bariatric surgery using propensity scores approach with a ratio of up to 1-to-5 by year. Inverse probability of censoring weighting was used to correct for potential informative censoring. Annual and cumulative hospital costs were assessed for the surgery and control groups. RESULTS: We identified 348 surgical patients (198 gastric bypass, 73 sleeve gastrectomy, 77 gastric banding) during the study period. In total, 324 surgical patients and 1506 matched control participants were included after propensity score matching. Mean 5-year cumulative hospital costs were €11,659 for 348 surgical patients. Compared with controls, surgical patients (n = 324) had significantly higher inpatient expenditures in the surgery year (€7289 vs. €2635, P < 0.001), but lower costs in the subsequent 4 years. The 5-year cumulative costs were €11,176 for surgical patients and €8759 for controls (P = 0.001). CONCLUSIONS: Bariatric surgery significantly increased the inpatient costs in the surgery year, but was associated with decreased costs in the subsequent 4 years. However, any cost savings made up to 4 years were not enough to compensate for the initial surgical expenditure.

Feasibility of Embedding a Scalable, Virtually Enabled Biorepository in the Electronic Health Record for Precision Medicine.

Importance: A cornerstone of precision medicine is the identification and use of biomarkers that help subtype patients for targeted treatment. Such an approach requires the development and subsequent interrogation of large-scale biobanks linked to well-annotated clinical data. Traditional means of creating these data-linked biobanks are costly and lengthy, especially in acute conditions that require time-sensitive clinical data and biospecimens. Objectives: To develop a virtually enabled biorepository and electronic health record (EHR)-embedded, scalable cohort for precision medicine (VESPRE) and compare the feasibility, enrollment, and costs of VESPRE with those of a traditional study design in acute care. Design, Setting, and Participants: In a prospective cohort study, the EHR-embedded screening alert was generated for 3428 patients, and 2199 patients (64%) were eligible and screened. Of these, 1027 patients (30%) were enrolled. VESPRE was developed for regulatory compliance, feasibility, internal validity, and cost in a prospective cohort of 1027 patients (aged ≥18 years) with sepsis-3 within 6 hours of presentation to the emergency department. The VESPRE infrastructure included (1) automated EHR screening, (2) remnant blood collection for creation of a virtually enabled biorepository, and (3) automated clinical data abstraction. The study was conducted at an academic institution in southwestern Pennsylvania from October 17, 2017, to June 6, 2019. Main Outcomes and Measures: Regulatory compliance, enrollment, internal validity of automated screening, biorepository acquisition, and costs. Results: Of the 1027 patients enrolled in the study, 549 were included in the proof-of-concept analysis (305 [56%] men); median (SD) age was 59 (17) years. VESPRE collected 12 963 remnant blood and urine samples and demonstrated adequate feasibility for clinical, biomarker, and microbiome analyses. Over the 20-month test, the total cost beyond the existing operations infrastructure was $39 417.50 ($14 880.00 project management, $22 717.50 laboratory supplies/staff, and $1820.00 data management)-approximately $39 per enrolled patient vs $239 per patient for a traditional cohort study. Conclusions and Relevance: Results of this study suggest that, in a large US health system that collects data using a common EHR platform and centralized laboratory system, VESPRE, a large-scale, inexpensive EHR-embedded infrastructure for precision medicine can be used. Tested in the sepsis setting, VESPRE appeared to capture a high proportion of eligible patients at low incremental cost.

Identifying the nature and extent of public and donor concern about the commercialisation of biobanks for genomic research.

Various forms of private investment are considered necessary for the sustainability of biobanks, yet pose significant challenges to public trust. To manage this tension, it is vital to identify the concerns of relevant stakeholders to ensure effective and acceptable policy and practice. This research examines the aspects of commercialisation that are of most concern to the Australian public (n = 800) and patients who had donated their tissue to two large disease specific (cancer) public biobanks (n = 564). Overall, we found a commercialisation effect (higher support for public relative to private) in relation to funding, research location and access to stored biospecimens. The effect was strongest for research locations and access compared to funding. A latent class analysis revealed the pattern of concern differed, with the majority (34.1%) opposing all aspects of commercialisation, a minority supporting all (15.7%), one quarter (26.8%) opposing some (sharing and selling tissue) but not others (research locations and funding), and a group who were unsure about most aspects but opposed selling tissue (23.5%). Patient donors were found to be more accepting of and unsure about most aspects of commercialisation. Members of the (general) public who were motivated to participate in biobanking were more likely to oppose some aspects while supporting others, while those who indicated they would not donate to a biobank were more likely to oppose all aspects of commercialisation. The results suggest that approaches to policy, engagement and awareness raising need to be tailored for different publics and patient groups to increase participation.

Improving Academic Biobank Value and Sustainability Through an Outputs Focus.

Although it is generally accepted that human tissue biobanks are important to facilitate progress in health and medical research, many academic biobanks face sustainability challenges. We propose that biobank sustainability is challenged by a lack of available data describing the outputs and benefits that are produced by biobanks, as reflected by a dearth of publications that enumerate biobank outputs. We further propose that boosting the available information on biobank outputs and using a broader range of output metrics will permit economic analyses such as cost-consequence analyses of biobank activity. Output metrics and cost-consequence analyses can allow biobanks to achieve efficiencies, and improve the quality and/or quantity of their outputs. In turn, biobank output measures provide all stakeholders with explicit and accountable data on biobank value, which could contribute to the evolution of biobank operations to best match research needs, and mitigate some threats to biobank sustainability.

BMI and Cause-Specific Hospital Admissions and Costs: The UK Biobank Cohort Study.

OBJECTIVE: To estimate the effect of BMI on cause-specific hospital admissions and costs in men and women is not well understood, and this study's aim is to address this. METHODS: For 451,320 men and women aged 40 years or older recruited into the UK Biobank, followed up for 6 years on average, this study estimated annual rates and costs (at 2016 UK prices) of hospital admissions, overall and by diagnostic category (using International Classification of Diseases, Tenth Revision chapters), in relation to BMI. RESULTS: Among those who were never smokers, a 2-kg/m2 higher BMI (above 20 kg/m2 ) was associated with a 6.2% (99% CI: 5.3% to 7.2%) higher admission rate and an 8.6% (99% CI: 7.3% to 10.0%) higher annual cost in men and with a 5.7% (99% CI: 4.9% to 6.6%) higher admission rate and an 8.4% (99% CI: 7.5% to 9.3%) higher annual cost in women. Higher BMI was associated with higher admission rates and costs for many types of health conditions, particularly for endocrine, skin, and musculoskeletal disorders in both men and women and for circulatory diseases in men. CONCLUSIONS: BMI beyond healthy weight is strongly associated with higher annual rates of hospital admission and higher costs in both men and women across a wide range of health conditions.

Digital Transformation and Governance Innovation for Public Biobanks and Free/Libre Open Source Software Using a Blockchain Technology.

Digitalization and digital health are transforming research practices, while economic growth is increasingly driven by the information commons. In the case of biological sciences, information commons, such as public biobanks and free/libre open source software (FLOSS), are of paramount importance for both research and the bioeconomy. In a time of digitalization, however, information commons are vulnerable to violations, such as the free-rider problem, that render the commons unsustainable. Consequently, it has been argued that the enclosure of the informational common resources is the only means to effectively exploit them. Given the social and economic importance of the information commons, the new digital environment in biology and health requires governance innovation that will regulate the social embedding of the commons and their relationship to the free market, that is, a new political economy is needed. In this context, the need for a core common infrastructure, stretching from the physical to the logical and content layer of the information environment, that will guarantee the protection of the commons from both violations and enclosures, has been highlighted. Focusing on the interaction between two biological/bioinformatics commons, namely public biobanks and the FLOSS, we have set up an ecosystem relying on a blockchain technology. The proposed governance mechanism protects the information commons from the free-rider problem and guarantees their sustainability without hampering their operational framework. Our model demonstrates the interdependence and protection of the information commons not as an abstract theoretical exercise, but rather as a physical reality on the digital ontological matrix.

From cold fusion to cold storage: A comparative case study of how organizational champions caused two scientific megaprojects to fail.

"Big science" has prompted scientific collaboration, ultimately leading to multidisciplinary, co-operative science. This has paved the way for organizational "champions", leading experts with the ability of driving organizational change. This study investigates the involvement of how "champions" contributed to the rapid failures of the 1980s case of the cold fusion initiative NCFI in Utah, and the 2000s case of BBMRI.se, the Swedish node of a biobank harmonization initiative, and how these two examples would become "failed scientific megaprojects". This descriptive comparative case study has utilized available literature and documents covering the two megaprojects, with some supplemental interviews. The study shows that "champions" indeed enable research but simultaneously also risk becoming the downfall of the collaborative endeavors that have been set up. Moreover, this study has been able to uncover and analyze some of the most common types of organizational failure found in the two failed scientific megaprojects investigated. The common lesson inferred from both cases is that the unquestionable trust placed into some of the "champions" led to a lack of procedural transparency and professional candidness, ultimately leading to a loss of trust from their respective funding bodies.

Donation of Human Biological Materials in the European Union: Commodifying Solidarity in the Era of the Biotechnological Revolution?

The use of human biological materials (HBMs) involves a number of issues from both an ethical and a legal point of view. In recent decades, the purposes for which this material has been used have increased. The development of therapeutic products has led to the configuration of a market in which products have acquired an economic value. As soon as the private sector crosses the threshold of access to the use of human cells and tissues, a conflict may arise between the altruistic principles motivating the act of donation and the profit-making objectives . When donated material emerges from the public management setting and becomes a source of profit, the instrument of informed consent may not adequately protect the dignity of the donors. In the era of medical biotechnology revolution, any use of the donated material must be justified and consistent with the values motivating the act of donation.

Toward a Synergistic Operating Model for Westmead Research Hub Biobanks: A Questionnaire Study.

Standardization and sustainability are ideals within the biobanking world, and the demand for high-quality well-annotated specimens is growing just as rapidly as the ever-increasing precision and throughput of today's high-tech scientific methods. In the state of New South Wales (NSW) in Australia, the state government has allocated significant funding toward this requirement in recent years, with the launch of the NSW Health Statewide Biobank in central Sydney in 2017, and the introduction of the voluntary NSW Biobank Certification Program, and Consent Toolkit. For new and established biobanks, the influence of these new resources has been twofold: first they have provided valuable guidance for moving toward standardized practices and raising the bar for biobanking quality standards; second, they have brought to the forefront the challenges of sustainability and transitioning to a certification standard of biobanking. In Westmead, ∼20 km from Sydney's central business district, the Westmead Research Hub has responded to these challenges with a collaborative biobanking project initiated in 2015. As the site of almost 30 individual biobanks, and to inform a pilot project of central biobank services, a questionnaire was developed and administered to all of the biobanks. This article reports on the results from the questionnaire and the rationale for subsequent initiation of a core biobanking facility.

The distribution and correlates of self-rated health in elderly Chinese: the China Kadoorie Biobank study.

BACKGROUND: Self-rated health (SRH) have been widely used as a valid indicator of health status at the population and individual level. We aimed to investigate the distribution and correlates of global SRH and age-comparative SRH in elderly Chinese. METHODS: Survey of 57,693 men and 67,089 women aged 60 years and above was conducted in five rural (Gansu, Sichuan, Hunan, Henan, Zhejiang) and five urban areas (Heilongjiang, Shandong, Jiangsu, Guangxi, Hainan) in China between 2004 and 2008. Logistic regression models were used to calculate the relations of different factors with global SRH and age-comparative SRH. RESULTS: Among the participants, 38.33% reported their global SRH as good or excellent while 61.67% as fair or poor, and 17.70% reported better age-comparative SRH while 17.99% as worse. In the multivariate model, compared to women, men tended to report a good global SRH and better age-comparative SRH, urban residents tend to report good global SRH and better age-comparative SRH. The socioeconomic and health behavior factors that were associated with good global SRH and better age-comparative SRH (with varying strengths of association) included: high educational level, high household income, house ownership, quitting smoking by own choices, occasional and current alcohol drinking, overweight, and high physical activity level. The factors that were associated with poor global SRH and worse age-comparative SRH included: quitting smoking by illness, former drinking, underweight, and weight lost ≥2.5 kg in the previous year. CONCLUSIONS: We found a moderate level of good global SRH and a low level of better age-comparative SRH among elderly Chinese. We identified a number of demographic, socioeconomic and health behavior factors that were related to SRH measures. Our study emphasizes the importance of incorporating both global and age-comparative SRH measures in future studies, and considering gender inequalities and urban/rural disparity, as well as socioeconomic status and health behaviors as important modifiers of health.

Advancing Professionalization of Biobank Business Operations: Performance and Utilization.

Biobanks are now in the spotlight as key enablers supporting preclinical, clinical, and environmental research. Awareness of their value has increased along with the need for these infrastructures to be sustained through business-focused practices. Following our 2017 pilot survey on biobank business planning, we initiated a more comprehensive 38-question multiple-language worldwide survey on biobank sustainability. Two hundred seventy-six biobanks of various sizes and stages of business planning (in place, in progress or none) responded. About two-thirds were established in the last 10 years. Survey results confirm our hypothesis that biobanks with business plans or preparing such plans are trending toward more professional structures. Specific survey data focusing on performance metrics and utilization, as related to sustainability, are presented. Biobanks most frequently measured basic performance metrics (sample utilization, samples collected, samples distributed, internal projects supported). Metrics less often reported included sample and data quality, cost recovery, citations, and publications, typically correlating with higher levels of biobank complexity and professionalism. Biobanks reported supporting projects for both internal and external use, with support of projects within their own organizations as the main driver of biobanks, independent of business plan status. Having a business plan seemed to be a key factor for biobanks that had developed sustained support for external commercial projects. While under half of the biobanks reported both target and actual utilization rates, the responses provided valuable data on utilization. Target utilization rates were much higher (2.5 to 5 times higher) than the rate of actual use. Many of the biobanks report less than 10% utilization. Biobanks with low utilization rates make sustainability a very distant and likely unreachable goal. Our survey has provided some basic data about biobank business planning globally. Continued research should be done, with the data and information shared within the community for the good of all biobank stakeholders.

The National MDS Natural History Study: design of an integrated data and sample biorepository to promote research studies in myelodysplastic syndromes.

Myelodysplastic syndromes (MDS), a spectrum of heterogeneous hematopoietic stem cell diseases, vary in clinical severity, response to therapy, and propensity toward progression to acute myeloid leukemia. These are acquired clonal disorders resulting from somatic mutations within the hematopoietic stem or progenitor cell population. Understanding the natural history and the risk of developing leukemia and other adverse outcomes is dependent on access to well-annotated biospecimens linked to robust clinical and molecular data. To facilitate the acquisition and distribution of MDS biospecimens to the wider scientific community and support scientific discovery in this disease, the National MDS Natural History study was initiated by the National Heart, Lung, and Blood Institute (NHLBI) and is being conducted in collaboration with community hospitals and academic medical centers supported by the National Cancer Institute (NCI). The study will recruit up to 2000 MDS patients or overlapping myeloproliferative neoplasms (MDS/MPN) and up to 500 cases of idiopathic cytopenia of undetermined significance (ICUS). The National MDS Natural History Study (NCT02775383) will offer the world's largest disease-focused tissue biobank linked to longitudinal clinical and molecular data in MDS. Here, we report on the study design features and describe the vanguard phase of 200 cases. The study assembles a comprehensive clinical database, quality of life results, laboratory data, histopathology slides and images, genetic information, hematopoietic and germline tissues representing high-quality biospecimens and data from diverse centers across the United States. These resources will be available to the scientific community for investigator-initiated research.

Next Chapter of the Taiwan Biobank: Sustainability and Perspectives.

The emergence of biobanks has expanded the scope of biomedical research, ushering in an era of "precision medicine" to improve the treatment of disease. However, biobanks also face sustainability challenges comprising three dimensions-"financial," "operational," and "social." The Taiwan Biobank (TWB), as a large-scale national biobank that supplies valuable phenotypic and genetic information to biomedical researchers on an application basis to investigate the relationship among personal health, genes, lifestyle, environment and diseases of the Taiwanese population, has not been sufficiently explored by researchers. Although the TWB has successfully reached a few milestones since its inception, it faces many sustainability challenges. For the next chapter of the TWB, we propose three strategies to improve sustainability. First, the Ministry of Health and Welfare launched the TWB as an infrastructure project under the leadership of Academia Sinica in 2012. We now believe that it is time that the TWB is transformed into a legal entity as a nondepartmental public body. This would not only ensure efficient, effective, and flexible operation, but would also facilitate cooperation with commercial entities. Second, we suggest that the TWB integrates with other Taiwanese biobanks to reduce cost, improve low utilization, and expand specimen collection. Third, self-financing is important if funding is ceased. Besides implementing a cost-recovery model, the commodities developed by the TWB (e.g., TWB 2.0 microarray) will help increase income. After each of these strategies has been discussed in detail, this article will conclude by highlighting how these practices can help improve biobank sustainability.